An interventional study of Electroacupuncture and Sham Acupuncture in Postoperative Pain, Stress, Psychological and Impacted Lower Third Molar, sponsored by University of Zagreb. Not yet recruiting at 1 site in Croatia. Open to participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by University of Zagreb · Not applicable, Interventional, and Treatment
This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.
Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation.
This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention.
An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Zagreb is the lead sponsor of 71 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive electroacupuncture for 15 minutes prior to administration of local anesthesia, according to a standardized protocol involving selected local and distal acupuncture points. Electrical stimulation is applied using a digital electroacupuncture device at an individually adjusted intensity sufficient to produce a clear sensation without pain or discomfort. Following the intervention, participants undergo standard surgical extraction of the impacted lower third molar under local anesthesia.
Procedure: Electroacupuncture
Participants receive a sham acupuncture procedure for 15 minutes prior to administration of local anesthesia. This involves superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation, mimicking the procedural aspects of electroacupuncture without therapeutic effect. The duration and conditions are identical to the electroacupuncture group. After the procedure, participants undergo standard surgical extraction under local anesthesia.
Procedure: Sham Acupuncture
Participants receive standard care consisting of local anesthesia and surgical extraction of the impacted lower third molar without any acupuncture intervention. All other aspects of perioperative management are consistent with routine clinical practice.
Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation.
Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect.
Perioperative Pain Intensity
Perioperative pain intensity assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores represent a worse outcome.
Time frame: Baseline and 30 minutes after surgical extraction
Perceived Stress
Perceived stress assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no stress and 10 indicates the highest perceived stress, and the 10-item Perceived Stress Scale (PSS-10); higher scores on both scales indicate greater perceived stress and a worse outcome.
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Cortisol Levels
Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Alpha-Amylase Levels
Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Substance P Levels
Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response.
Time frame: Baseline and 30 minutes after surgical extraction
Systolic Blood Pressure
Systolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).
Time frame: Baseline and immediately after surgical extraction
Diastolic Blood Pressure
Diastolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).
Time frame: Baseline and immediately after surgical extraction
Heart Rate
Heart rate measured using a validated automated digital monitor as an indicator of autonomic response, reported in beats per minute (bpm).
Time frame: Baseline and immediately after surgical extraction
Plan to share: No — Individual participant data will not be shared due to privacy considerations and the absence of a predefined data-sharing plan within this investigator-initiated study. Data will be reported in aggregate form in scientific publications.
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Oct 2026, 5 months later.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 5 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Zagreb